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Leflunomide 20 mg Tablets Under Fasting Conditions

NCT00834418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-08-20

Study results available
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Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Leflunomide 20 mg Tablets

1 x 20 mg, single-dose fasting

DRUG

ARAVA™ 20 mg Tablets

1 x 20 mg, single-dose fasting

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • James D. Carlson, Pharm.D. · PRACS Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2002-07-31
Completion
2002-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00834418 on ClinicalTrials.gov